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Family Relationship, Family Health, Happiness and HarmonyNCT01720992

Enhancing Family Well-being Project

A study testing A theory-based action planning toolkit in people with Family Relationship, Family Health, Happiness and Harmony, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Shamshuipo District has the highest proportion of low income families, and a relatively large percentage of single parents, elderly, new immigrants among all districts in Hong Kong (Census and Statistics Department, 2011). Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
What is being tested?
A theory-based action planning toolkit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 siteChina
Study dates
Mar 2012to Apr 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • For the launching event, the community-based programmes, and focus groups of participants:
  • Participants aged six or above, who can communicate with social workers, and who are currently residing in Shamshuipo District /are service users of the corresponding NGO/ are students in Shamshuipo District. Participants who are between six and eight years old are required to be assisted individually by social workers in completing questionnaires.
  • For the social workers' training programme, the practice wisdom forum, focus groups of social workers:
  • Social or community workers who can read Chinese and speak Cantonese, and are currently working in selected social service organizations or government agencies in the Shamshuipo District.
  • In-depth interviews of community stakeholders:
  • Community stakeholders who can read Chinese and speak Cantonese, and are currently working in the social service organizations (participate or not participant in this project) or government agencies in the Shamshuipo District.

Who cannot join

  • Participants who fail to meet the inclusion criteria

Trial locations and contacts

1 site in 1 country.

China1 site
  • The University of Hong Kong

    Hong Kong SAR

Other trials in China

About this study

Background: Shamshuipo District has the highest proportion of low income families, and a relatively large percentage of single parents, elderly, new immigrants among all districts in Hong Kong (Census and Statistics Department, 2011). In addition to provide these families substantial support, a campaign to enhance their family well-being is needed.

Aim: This project is conducted to enhance their family relationship as well as family happiness, health and harmony (3Hs) among families in the Shamshuipo District, through a community-based intervention programme combined with a planning tool (booklet).

Read more

Methods: This project adopts a cluster-randomized controlled design, with the application of positive psychology concepts as a theoretical framework. A community-based participatory (CBP) approach, which is an effective way to engage public health researchers and community members (NGOs, other major stakeholders, and participants), will be used. Both quantitative and qualitative methods will be used in the evaluation of major outcomes (participants' family relationship and 3Hs) at different time points throughout the project. Process evaluation will be performed to evaluate the process of each component of the project.

Procedure: This project will be conducted in three phases.

Phase 1 includes planning, implementation, and evaluation of a training programme for social workers from the 30 participating NGOs. The social workers will be equipped with the knowledge and skills of the application of positive psychology as well as logic model. This phase also includes the launching event to arouse public awareness of the project.

Phase 2 includes designing, delivering, and evaluating 30 community-based intervention programmes. A planning tool (designed as a booklet) will be distributed to participants of the intervention group in the form of 'homework assignment' immediate after the intervention programme; whereas participants of the control group will receive the booklet upon the completion of the three months follow-up questionnaire assessment. This phase also contains focus group interviews among participants to collect their experiences, feelings and changes in families after attending the intervention programme. Focus groups among social workers will be conducted afterwards to explore their barriers and facilitators in programme implementation; as well as their personal and/or collective growth in conducting the project. In-depth interview among community stakeholders will be held to explore the social impact of the CBPR project, and collect their suggestions for future implementation.

Phase 3 is a dissimilation phase that the "Positive Family Education Booklet" and "Positive Family Practice Manual" will be released. A practice wisdom forum for social workers and other major stakeholders will also be organized to share their experiences in conducting the community-based programmes.

Primary hypothesis: Families participated in a community-based programme and received a toolkit (intervention group) have higher scores in their family relationship and family 3Hs than families who participated in a community-based programme only (control group).

Secondary hypotheses: (1) Participants' attitudes towards and intention of practising the suggested behaviours will be increased immediately after their participation in the community-based intervention programme; (2) Participants' attitudes towards, their intention, as well as frequency of practising the suggested behaviours will remain higher at 6 weeks and 3 months after the intervention compared to the corresponding figures of pre-intervention (baseline); (3) Participants' scores of family relationship and 3Hs will be significantly higher at 6 weeks and 3 months after their participation in the intervention.

Read the detailed description

Shamshuipo District consists of 5.3% of the population in Hong Kong; and ranks the fourth most densely populated district in 2010 (Social Welfare, 2011). The proportion of single parents, elderly, newly immigrated mainland persons, ethnic minorities, comprehensive social security assistance recipients in this district are relatively high; whereas the median of monthly domestic household income is the lowest among all districts in Hong Kong (Census and Statistics Department, 2011). It is essential to provide substantial support for families with low income and under privileged condition. Apart from this, encouraging positive thinking among family members may be an effective way to enhance family well-being in this district (Linley et al., 2011). A considerable amount of evidence has demonstrated benefits of applying positive psychology principles on family well-being. Previous studies including the 'nun study' (Danner et al., 2001) and Harvard study (Peterson et al., 1988) suggested that people who are happy tend to be healthier and live longer.

'The Shamshuipo Well-being Movement' ('The Movement'), which adopted a positive psychology approach (Seligman \& Csikszentmihalyi, 2000) to promote four character strengths ('gratitude', 'hope', 'resilience', and 'open-mindedness') among their residents to enhance family well-being had been initiated in the past two years, under the coordination of Social Welfare Department (SWD) of Shamshuipo District. Building on the success of 'The Movement', a community-based initiative named 'Enhancing Family Well-Being Project' is collaboratively developed between SWD of Shamshuipo District and the School of Public Health, the University of Hong Kong. This project will focus on training and mobilizing local community stakeholders, and developing, delivering, and evaluating community-based programmes for families in Shamshuipo District, to arouse public interests towards an enhanced family relationship, as well as family health, happiness, and harmony (3Hs). The collaboration is based on evidence that community-based participatory (CBP) approach provides an effective way to engage public health researchers and community members (NGOs, other major stakeholders, and participants) in an active partnership to take action, in order to promote social change (White et al., 2004; Macaulay, 2007; Berge et al., 2009; Shalowitz et al., 2009).

This project also adopts a cluster-randomized controlled design to evaluate the effectiveness of a theory-based action planning toolkit . The toolkit will be distributed to the participants for their use at home, like a 'homework assignment', for the purpose of enhancing their intention and practices of the suggested behaviours. The development of the booklet was guided by the theory of The Health Action Process Approach (HAPA), which suggests that one's intention can be foster by knowing that the new behaviour has positive outcomes as opposed to the negative outcomes that accompany the current behaviour; and planning (action planning and coping planning) serves as an operative mediator between intentions and behaviour (Schwarzer, 2008). Previous evidence has shown the applicability of the HAPA in changing people's health behaviours, e.g., physical exercise, breast self-examination, seat belt use, dietary behaviours, and dental flossing; and its generalizability has been confirmed by Schwarzer (2008).

In summary, this is a community-based participatory research (CBPR) project using a cluster-randomized controlled design; and applying positive psychology concepts to develop community-based interventions with a theory-based toolkit, in an attempt to enhance family relationship and family 3 Hs in the Shamshuipo District.

The aim of this study is to assess the effectiveness of a community-based intervention programme (with the application of positive psychology) with a theory-based toolkit among families in the Shamshuipo District, on enhancing their family relationship and family 3Hs.

The specific objectives of the study include:

  1. To investigate the effectiveness of the community-based intervention programmes in improving family relationship and family 3Hs;
  2. To evaluate the effectiveness of a theory-based toolkit in increasing participants' intention and practices of the suggested behaviours; as well as enhancing their family relationship;
  3. To evaluate the various components of the project in terms of its structure, process, and outcomes;
  4. To engage and build capacity of the social workers through training programmes on the application of positive psychology and logic model;
  5. To explore the social impact of the CBPR in collaboration with various NGOs and stakeholders in the Shamshuipo District.
Being tested
A theory-based action planning toolkit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A theory-based action planning toolkitOther

    The toolkit will be distributed to the participants for their use at home, like a 'homework assignment', for the purpose of enhancing their intention and practices of the suggested behaviours. The development of the booklet was guided by the theory of The Health Action Process Approach (HAPA), which suggests that one's intention can be foster by knowing that the new behaviour has positive outcomes as opposed to the negative outcomes that accompany the current behaviour; and planning (action planning and coping planning) serves as an operative mediator between intentions and behaviour (Schwarzer, 2008). Previous evidence has shown the applicability of the HAPA in changing people's health behaviours, e.g., physical exercise, breast self-examination, seat belt use, dietary behaviours, and dental flossing; and its generalizability has been confirmed by Schwarzer (2008).

Study groups in NCT01720992
Study groupRoleWhat they receive
Group AExperimentalA theory-based action planning toolkit will be distributed to Group A participants.
Receives: Other: A theory-based action planning toolkit
Group BOtherGroup B is a wait list control
Receives: Other: A theory-based action planning toolkit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Family relationship from baseline to 3 months after intervention

    Family relationship will be assessed by a 'Family relationship scale'of Family environmental scale.

    Measured: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs

  2. Changes in family happiness from baseline to 3 months after intervention

    Happiness will be determined by Subjective Happiness Scale and the one item question adopted from Subramanian et al. Self-perceived happiness at the individual and family level will also be assessed by a 0-10 score at 4 time points.In addition to the quantitative methods described above, qualitative method (focus group) will be conducted to evaluate the primary outcomes.

    Measured: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs

  3. Changes in family health from baseline to 3 months after intervention

    Health will be evaluated by the SF-12v2 Health Survey. Harmony will be assessed by a 12-item scale. Self-perceived health, at the individual and family level will also be assessed by a 0-10 score at 4 time points.In addition to the quantitative methods described above, qualitative method (focus group) will be conducted to evaluate the primary outcomes.

    Measured: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs

  4. Changes in family harmony from baseline to 3 months after intervention

    Harmony will be assessed by a 12-item scale. Self-perceived harmony, at the individual and family level will also be assessed by a 0-10 score at 4 time points.In addition to the quantitative methods described above, qualitative method (focus group) will be conducted to evaluate the primary outcomes.

    Measured: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs

Secondary outcomes (14)
  1. Changes in Participants' attitudes towards, intention and frequency of performing the suggested behaviors from baseline to 3 months after intervention

    Questionnaire will be used to evaluate the changes in participants' attitudes towards, intention and frequency of performing the suggested behaviors from baseline to 3 months after intervention

    Measured: Pre-intervention program (Up to 2 weeks before) (T1), immediate post- intervention program (Up to 2 weeks after) (T2), six weeks (T3) and three months (T4) after intervention programs.

  2. Changes in Social workers' knowledge of the application of positive psychology in the CBPR project before and after training session

    Questionnaire will be used to investigate the changes in Social workers' knowledge of the application of positive psychology in the CBPR project before and after training session

    Measured: Pre- and post- training session (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up

  3. The process of community-based intervention programme

    Assessed by a Process Evaluation onsite observation form, and a series of checklists including Resources input record sheet, Participants' attendance form, Programme rundown, Booklet record form, and NGOs' final report. The components of process evaluation, including context, reach, dose delivered, dose received, fidelity and recruitment will be assessed.

    Measured: Observe in every session of the community-based intervention programme, including core intervention session, booster session (6 weeks after the core intervention), and tea-gathering (3 months after the core intervention).

  4. The social impact of the CBPR project

    Evaluated by conducting community stakeholders' in-depth interviews.

    Measured: Post intervention program (Up to 3 months after)

  5. Changes in social workers' attitudes of the application of logic model in the CBPR project before and after training session

    Questionnaire will be used to access the changes in social workers' attitudes of the application of logic model in the CBPR project before and after training session

    Measured: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up

  6. Changes in Social workers' self-competency of the application of process evaluation in the CBPR project before and after training session

    Questionnaire will be used to evaluate the changes in social workers' self-competency of the application of process evaluation in the CBPR project before and after training session

    Measured: Pre- and post- training (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up

  7. Changes in Social workers' attitude of the application of positive psychology in the CBPR project before and after training session

    Questionnaire will be used to access the changes in social workers' attitude of the application of positive psychology in the CBPR project before and after training session

    Measured: Pre- and post- training session (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up

  8. Changes in Social workers' self-competency of the application of positive psychology in the CBPR project before and after training session

    Questionnaire will be used to access the changes in social workers' self-competency of the application of positive psychology in the CBPR project before and after training session

    Measured: Pre- and post- training session (Up to 2 weeks before and after); as well as a 6-month, and 12-month follow-up

  9. Changes in social workers' knowledge of the application of logic model in the CBPR project before and after training session

    Questionnaire will be used to investigate the changes in social workers' knowledge of the application of logic model in the CBPR project before and after training session

    Measured: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up

  10. Changes in social workers' self-competency of the application of logic model in the CBPR project before and after training session

    Questionnaire will be used to evaluate the changes in social workers' self-competency of the application of logic model in the CBPR project before and after training session

    Measured: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up

  11. Changes in Social workers' knowledge of the application of process evaluation in the CBPR project before and after training session

    Questionnaire will be used to evaluate the changes in social workers' knowledge of the application of process evaluation in the CBPR project before and after training session

    Measured: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up

  12. Changes in Social workers' attitude of the application of process evaluation in the CBPR project before and after training session

    Questionnaire will be used to access the changes in social workers' attitude of the application of process evaluation in the CBPR project before and after training session

    Measured: Pre- and post- training (Up to 2 weeks before and after) ; as well as a 6-month, and 12-month follow-up

  13. Changes in Participants' intention of performing the suggested behaviours from baseline to 3 months after intervention

    Questionnaire will be used to evaluate the changes in participants' attitudes towards, intention and frequency of performing the suggested behaviours from baseline to 3 months after intervention

    Measured: Pre-intervention program (Up to 2 weeks before) (T1), immediate post- intervention program (Up to 2 weeks after) (T2), six weeks (T3) and three months (T4) after intervention programs.

  14. Changes in Participants' frequency of performing the suggested behaviors from baseline to 3 months after intervention

    Questionnaire will be used to evaluate the changes in participants' attitudes towards, intention and frequency of performing the suggested behaviors from baseline to 3 months after intervention

    Measured: Pre-intervention program (Up to 2 weeks before) (T1), immediate post- intervention program (Up to 2 weeks after) (T2), six weeks (T3) and three months (T4) after intervention programs.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionJan 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720992
Sponsor's protocol ID
EFWBP
Status last verified
Feb 2014
First submitted
30 Aug 2012
Last updated
5 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing A theory-based action planning toolkit in people with Family Relationship, Family Health, Happiness and Harmony, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Family relationship from baseline to 3 months after intervention (time frame: Pre-intervention programs (Up to 2 weeks before), post-intervention programs (Up to 2 weeks after), six weeks and three months after intervention programs). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014.

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